User's Manual

Precision Spectra System Clinical Summary
Precision Spectra™ System Information for Prescribers
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treatment reduced the pain by 50%, the systems were internalized. A retrospective analysis
of patients with unilateral leg and/or buttock pain treated initially with SCS and bilateral leg or
mainly low back pain treated initially with spinal infusions of opioids was then done.
In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation;
16 (38%) received opioids via a spinal infusion pump. Five patients did not receive adequate
pain relief with SCS; 3 (7%) of these patients underwent trial spinal infusions and had effective
pain relief.
There were 4 (10%) patients who underwent a trial of spinal infusion of opioid but did not
receive adequate pain relief; these patients were not tested with SCS. Pain severity was
rated using a verbal digital pain scale: “On a scale of 0 to 10 where 0 is no pain and 10 is the
worst pain you could ever imagine, what is your pain now?” 16/26 patients (62%) had greater
than 50% pain relief with SCS. In this study, 2/16 (13%) had greater than 50% pain relief
with opioids. Mean follow-up was 2.1 ± 0.3 years. This analysis supports the use of SCS for
intractable low back and leg pain.
In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%)
patients required repositioning of catheter type electrodes and 2 patients required revision of
the stimulator generator.
Safety Evaluation
Eleven studies were identifi ed based on the detailed inclusion/exclusion criteria to demonstrate
the safety of the Precision Spectra™ System. The studies included a total of 1056 patients that
were trialed with SCS systems and 880 patients that received implants. The table below depicts
the number of patients, the number of events, and the percentage of occurrences of each event
compared to the total number of patients. It should be noted that citations cover both IPG and
RF Systems. The clinical experience reported in the literature on RF systems is relevant to
determining the safety of totally implantable IPG systems.